FDA.reportPublic FDA data

Cephalexin

Product NDC
80425-0006
11-digit product format
804250006
Labeler code
80425
Product ID
80425-0006_2a97df38-1192-6d39-e063-6394a90a34c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
ADVANCED RX PHARMACY OF TENNESSEE, LLC
Application
ANDA065229
Marketing category
ANDA
Marketing start
2006-01-11
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOBN7UDS42Y
Rxcui309114

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dfa3f520-409c-432e-b6d3-9250d468c772Product name120250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0006-1Cephalexin28 in 1 BOTTLECAPSULE287
80425-0006-2Cephalexin40 in 1 BOTTLECAPSULE407

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0006-1EA - Each80425-00066dc0c037-4f24-4b9a-831b-0f0b38fd372612023-03-13
80425-0006-2EA - Each80425-0006d72e15f1-4bbf-47ce-9237-10e002d102dc12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0006CEPHALEXIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_af4abf8b-22cc-da58-e053-2a95a90aa766.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNaf4abf8b-22cc-da58-e053-2a95a90aa7667
309114cephalexin 500 MG Oral CapsuleSCDaf4abf8b-22cc-da58-e053-2a95a90aa7667
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYaf4abf8b-22cc-da58-e053-2a95a90aa7667

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0006-18042500060128 CAPSULE in 1 BOTTLE (80425-0006-1) 28 capsule2006-01-110000-00-00NoNoCurrent
80425-0006-28042500060240 CAPSULE in 1 BOTTLE (80425-0006-2) 40 capsule2006-01-110000-00-00NoNoCurrent